The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers

Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app. In Phase 1, the investigators will develop and refine the intervention with input from direct care workers who serve at-risk perinatal women. In Phase 2, direct care workers will deploy the training to expectant mothers with sleep concerns and the investigators will assess the reach, effectiveness, adoption, implementation, and maintenance of this scalable, efficient intervention to improve sleep.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Sleep; Postpartum Depression; Sleep Disturbance; Pregnancy Related; Sleep Deprivation; Sleep Hygiene
• Intervention / Treatment: Behavioral: Education about behavioral strategies to improve sleep

Detailed Description

Disrupted, insufficient sleep occurs in the majority of pregnant women and increases the risk of negative health consequences for mothers and their infants, including pregnancy and childbirth complications as well as chronic illnesses, such as major depression and weight retention/obesity. Conventionally, perinatal sleep disturbances have been viewed as expected and intractable, but recent studies demonstrate that behavioral interventions are effective for improving sleep in pregnant and postpartum women. Nevertheless, efficient, scalable sleep interventions that are tailored to expectant and new mothers are scarce. This Administrative Supplement for Research on Women's Health seeks to develop a high-fidelity, evidence-based sleep intervention in collaboration with direct care workers who engage with perinatal women and to collect preliminary data regarding delivery of the resulting intervention to expectant and new parents. This pilot project is grounded in the RE-AIM framework, and will assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance dimensions of this model to prepare for a large-scale future R01 hybrid effectiveness-implementation trial. In Phase 1, the investigators will develop short, evidence-based, educational videos in English (with Spanish subtitles) that focus on improving perinatal sleep and that map onto modules in the free, publicly-available mobile app, CBTi Coach. Videos will be produced and refined in cooperation with direct care workers and a video production company with community engagement experience. Direct care workers who work with perinatal women will be trained to deliver the intervention (target n=35). In Phase 2, direct care workers will be invited to use the intervention with clients who report sleep problems and the investigators will study implementation in workers and clients (target n=20).

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine M Sharkey, MD, PhD; Phone Number: 401-793-3497; Email: katherine_sharkey@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: Katherine M Sharkey, MD, PhD; Phone Number: 401-793-3497; Email: katherine_sharkey@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Phase 1 Inclusion Criteria:

To qualify for Phase 1 enrollment, participants must be:

• over 18 years of age;
• working with expectant and new mothers in a community setting (i.e., outpatient clinic, social service agency, home visiting program, community center);
• in a role where they would be expected to meet with the same client on at least 4 occasions during the perinatal period; in situations where a team-based approach is used to provide services and a client may not see the exact same person at each visit, team members will qualify if they all enroll in the study (e.g., two nurse midwives who provide coverage for each other may both enroll);
• have access to a smart phone to view the training videos, complete the assessments, and access the free CBTi Coach app; speak and read English or Spanish;
• express interest in providing their clients with additional tools to manage sleep disturbances in pregnancy and the postpartum period.

Phase 1 Exclusion Criteria:

The investigators will exclude potential participants who:

• already have certification or a specialty in perinatal sleep (e.g., therapists with formal training in CBTi, individuals with sleep coaching practices);
• those who do not have longitudinal relationships with clients (e.g., intake workers).

Phase 2 Inclusion Criteria:

To qualify, Phase 2 participants must be:

• expectant parents OR new parents up to 1 year postpartum;
• age 18 to 45 years old;
• receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1;
• speak and read English or Spanish;
• have access to a smart phone to view the training videos and complete the assessments;
• have clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7.

Phase 2 Exclusion Criteria:

The investigators will exclude potential participants whose infants will not be living in the home or who will have a nighttime caregiver.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Visitors; The participants in Phase 1 of the proposed study are individuals who provide services to perinatal women who are at risk of postpartum depression. The investigators will recruit 35 adults ages 18 years or older who provide health, well-being, and/or mental health services/treatment to pregnant and postpartum women to participate in Phase 1 of this study. Job titles that meet inclusion criteria include nurses, nurse practitioners, family support workers, therapists, counselors, doulas, lactation consultants, childbirth educators, social workers, public health workers, midwives, and nurse midwives. The investigators will not select participants based on age, gender, sex, or racial or ethnic identity.	Behavioral: Education about behavioral strategies to improve sleep; In collaboration with direct care workers, the investigators are developing an intervention to help home visitors support clients who experience sleep difficulties in the perinatal period. The intervention consists of a series of educational videos about promoting healthy sleep and addressing sleep difficulties during pregnancy and the postpartum period.; Other Names: Dream Team Training
Experimental: Expectant and New Parents; Phase 2 participants will be given access to the educational materials about sleep and the investigators will collect information about their sleep. To qualify for enrollment, Phase 2 participants must be: expectant parents OR new parents up to 1 year postpartum; 18 to 45 years old; receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1; speak and read English or Spanish; have access to a smart phone to view the training videos and complete the sleep diaries and assessments; are experiencing clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7 The investigators will exclude potential participants who are parents whose infants will not be living in the home or who will have a nighttime caregiver	Behavioral: Education about behavioral strategies to improve sleep; In collaboration with direct care workers, the investigators are developing an intervention to help home visitors support clients who experience sleep difficulties in the perinatal period. The intervention consists of a series of educational videos about promoting healthy sleep and addressing sleep difficulties during pregnancy and the postpartum period.; Other Names: Dream Team Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 Reach	Reach: Number of eligible workers who enroll in the training and number of workers who complete the training	Throughout training period, i.e., for about 6 months; one time measure.
Phase 1 Effectiveness	Effectiveness: Participants are tested before and after training on sleep and circadian rhythm knowledge. Questions are based on the learning objectives for the educational modules. A successful outcome will be defined as >= 70% of sleep knowledge questions answered correctly.	At enrollment and 1 month after training.
Phase 1 Acceptability	Acceptability: Participants will complete an online questionnaire to assess their perceptions of the training videos including Likert scales where they will report on (a) how prepared they feel to deliver the intervention; (b) ease of use; (c) compatibility with other resources they provide; and (d) the likelihood that they will use the app with their clients. This questionnaire will also include a short answer section for participants to report facilitators and barriers to use of the intervention.	1 month after training
Phase 2 Reach	Reach: Investigators will track what percent of clients who are referred actually enroll, the number of pregnant vs. postpartum women who enroll, and the number of fathers/partners who enroll.	one time measure during enrollment period, ~ 6 months
Phase 2 Effectiveness	Effectiveness: Clients will complete a brief survey to assess their perceptions of the acceptability and utility of the intervention.	6 weeks after enrollment
Phase 2 Effectiveness - Insomnia Severity Index	Participants will complete the 7-item Insomnia Severity Index (ISI, range 0-28, higher scores indicate more sleep disturbance) at enrollment and 6 weeks after enrollment.	at enrollment and 6 weeks after enrollment
Phase 2 Effectiveness - Implementation	Implementation: After clients enroll, investigators will assess quantitative implementation measures related to whether clients engage with the intervention as intended through metadata provided by the app and website (i.e., time spent on the app in minutes and time spent viewing videos in minutes).	from enrolllment through 6 weeks after enrollment

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: Bradley Hospital
• Investigators: Principal Investigator: Katherine M Sharkey, MD, PhD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: education; implementation; RE-AIM; Home visitors; sleep diaries
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Sleep Wake Disorders; Mood Disorders; Dyssomnias; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; Sleep Deprivation
• Other Study ID Numbers: 1848819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final computerized research datasets will include both raw and summary data as well as documentation so that others can make use of the data. These data represent a valuable public resource and the investigators strongly support the notion that other researchers will be able to capitalize on the efforts and funding that go into collecting and processing these data.
• IPD Sharing Time Frame: The informed consent documents will be posted on a federal website after enrollment closes and no later than 60 days after the last study visit of any participant. English language consent forms will be posted at ClinicalTrials.gov and Non-English consent forms will be posted to Regulations.gov. Additionally, results will be reported no later than one year after the actual completion date listed in ClinicalTrials.gov.
• IPD Sharing Access Criteria: By request to the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No